Description:

This role is responsible for defining and specifying the activities, processes,
and standards required to fulfill quality requirements for manufactured
materials, components, and products within a global pharmaceutical environment.
The position builds and maintains the infrastructure and systems necessary to
consistently ensure the timely delivery of quality-compliant products. It
supports the development, implementation, and maintenance of the Quality
Management System to ensure organizational compliance with regulatory and
internal standards. The role ensures effective and effective workflows,
procedures, policies, and inspection programs are in place and adhered to across
operations. It manages in-process product quality in coordination with vendors
and contract manufacturers. The position facilitates communication with
customers and vendors to resolve quality-related issues in a timely and
compliant manner. It reports and troubleshoots manufacturing process deviations
and defects identified in finished goods. The role contributes to continuous




improvement initiatives aimed at reducing defects, errors, and rework across
operations. It also supports the identification and development of outsourcing
vendors and suppliers according to organizational quality standards.

Essential Functions:
* Define and specify quality activities, processes, and standards for the
Quality Management System in compliance with regulatory requirements

* Build and maintain quality infrastructure and systems to ensure timely
delivery of compliant pharmaceutical products

* Conduct audits and monitoring of processes and outputs against internal and
regulatory standards including 21 CFR Part 210 & 211 and GMP guidelines

* Ensure efficient workflow, procedures, policies, and inspection programs are
implemented and maintained across operations

* Manage in-process product quality in coordination with vendors and contract
manufacturers to meet defined quality specifications

* C

📌 Trainee Executive, QMS (India)
🏢 Amneal India
📍 India